04.01.16
The U.S. Senate confirmed the appointment of Dr. Robert Califf, MD, as commissioner of the U.S. Food and Drug Administration, which regulates about a quarter of every dollar spent in the U.S.
Dr. Califf, a cardiologist and clinical researcher from Duke University, previously served as the FDA’s Deputy Commissioner for Medical Products and Tobacco since February 2015.
Dr. Stephen Ostroff, who had served as the acting FDA commissioner following the resignation of Margaret Hamburg, commented on the approval, saying, “Dr. Califf has demonstrated a long and deep commitment to advancing the public health throughout his distinguished career as a physician, researcher and leader in the fields of science and medicine. He understands well the critical role that the FDA plays in responding to the changes in our society while protecting and promoting the health of the public, across the many areas we regulate—and I am confident that our public health and scientific contributions will further grow under his exceptional leadership.”
Steven Tave was also recently named acting director of the Office of Dietary Supplement Programs (ODSP) at FDA. Mr. Tave takes the place of Dr. Robert Durkin, who has been the acting director since May 2015.
“The dietary supplement industry is growing at a rapid rate and it is critical that ODSP utilizes all resources at its disposal to increase enforcement against deliberate criminal activity and protect consumers,” said Daniel Fabricant, PhD, executive director and CEO of the Natural Products Association. “NPA commends Robert Durkin for his leadership during his time as the acting director. NPA looks forward to working with Mr. Tave on increasing the visibility and attention for dietary supplement safety and compliance measures.”
Steve Mister, president and CEO of the Council for Responsible Nutrition (CRN), applauded the confirmation of Dr. Califf, calling it “pivotal” for the agency as well as the dietary supplement and functional food industries.
“Based on his confirmation hearing, we feel confident that Dr. Califf will be fully committed to enforcing the laws and regulations for our industry that help protect consumers,” he said. “Further, we hope the commissioner will continue the agency’s recent enforcement actions taken in conjunction with the Department of Justice to help rid the marketplace of the most egregious companies defaming our industry and posing the highest risk to consumers. Dr. Califf’s demonstrated leadership at the agency, paired with the recent elevation of the Division of Dietary Supplement Programs to ‘Office’ status, will enhance the agency’s ability to fulfill its regulatory responsibilities. As our industry continues to grow and evolve, we look forward to having a strong leader in place and working with Dr. Califf and his team on public health issues.”
Loren Israelsen, president, United Natural Products Alliance (UNPA), said he is hopeful that Dr. Califf will work with the new Office of Dietary Supplement Programs and use the authority offered by the Dietary Supplement Health and Education Act (DSHEA) “to protect and preserve consumer access to safe and beneficial dietary supplements.”
“We have been most encouraged by recent FDA efforts to identify and to then take action against clear violations of the law,” Mr. Israelsen said. “We have also been encouraged by recent FDA statements in support of the positive steps taken by companies and industry to provide Americans high quality products while ensuring consumer safety. UNPA’s ongoing series of supplement quality summits, including the just completed Raw Materials & Supply Chain Summit, are just the most recent examples of industry’s commitment to exactly those principles.”
Dr. Califf, a cardiologist and clinical researcher from Duke University, previously served as the FDA’s Deputy Commissioner for Medical Products and Tobacco since February 2015.
Dr. Stephen Ostroff, who had served as the acting FDA commissioner following the resignation of Margaret Hamburg, commented on the approval, saying, “Dr. Califf has demonstrated a long and deep commitment to advancing the public health throughout his distinguished career as a physician, researcher and leader in the fields of science and medicine. He understands well the critical role that the FDA plays in responding to the changes in our society while protecting and promoting the health of the public, across the many areas we regulate—and I am confident that our public health and scientific contributions will further grow under his exceptional leadership.”
Steven Tave was also recently named acting director of the Office of Dietary Supplement Programs (ODSP) at FDA. Mr. Tave takes the place of Dr. Robert Durkin, who has been the acting director since May 2015.
“The dietary supplement industry is growing at a rapid rate and it is critical that ODSP utilizes all resources at its disposal to increase enforcement against deliberate criminal activity and protect consumers,” said Daniel Fabricant, PhD, executive director and CEO of the Natural Products Association. “NPA commends Robert Durkin for his leadership during his time as the acting director. NPA looks forward to working with Mr. Tave on increasing the visibility and attention for dietary supplement safety and compliance measures.”
Steve Mister, president and CEO of the Council for Responsible Nutrition (CRN), applauded the confirmation of Dr. Califf, calling it “pivotal” for the agency as well as the dietary supplement and functional food industries.
“Based on his confirmation hearing, we feel confident that Dr. Califf will be fully committed to enforcing the laws and regulations for our industry that help protect consumers,” he said. “Further, we hope the commissioner will continue the agency’s recent enforcement actions taken in conjunction with the Department of Justice to help rid the marketplace of the most egregious companies defaming our industry and posing the highest risk to consumers. Dr. Califf’s demonstrated leadership at the agency, paired with the recent elevation of the Division of Dietary Supplement Programs to ‘Office’ status, will enhance the agency’s ability to fulfill its regulatory responsibilities. As our industry continues to grow and evolve, we look forward to having a strong leader in place and working with Dr. Califf and his team on public health issues.”
Loren Israelsen, president, United Natural Products Alliance (UNPA), said he is hopeful that Dr. Califf will work with the new Office of Dietary Supplement Programs and use the authority offered by the Dietary Supplement Health and Education Act (DSHEA) “to protect and preserve consumer access to safe and beneficial dietary supplements.”
“We have been most encouraged by recent FDA efforts to identify and to then take action against clear violations of the law,” Mr. Israelsen said. “We have also been encouraged by recent FDA statements in support of the positive steps taken by companies and industry to provide Americans high quality products while ensuring consumer safety. UNPA’s ongoing series of supplement quality summits, including the just completed Raw Materials & Supply Chain Summit, are just the most recent examples of industry’s commitment to exactly those principles.”
